Clinical Trials Directory

Trials / Unknown

UnknownNCT01099462

Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

Status
Unknown
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Assaf-Harofeh Medical Center · Other Government
Sex
All
Age
3 Months – 18 Years
Healthy volunteers
Not accepted

Summary

Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children. There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF). The objective of the current study is to describe concentrations of ibuprofen in the CSF of infants and children after administration of ibuprofen. We will study infants presenting to the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup including sampling of blood and CSF is conducted in cases of suspected meningitis. We will measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will unable us to suggest more accurate dosing guidelines, and to better predict the effects of this commonly used drug.

Conditions

Interventions

TypeNameDescription
DRUGIbuprofenIbuprofen (10mg/kg BW) will be given orally if the temperature on presentation is higher than 38.0OC according to the decision of the attending physician.

Timeline

Start date
2007-06-01
Primary completion
2010-12-01
Completion
2011-06-01
First posted
2010-04-07
Last updated
2010-04-07

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01099462. Inclusion in this directory is not an endorsement.